The U.K.’s drug marketing watchdog, the PMCPA, is having a busy summer. It flagged five companies for an array of breaches of its code, and, in fact, two of them were hit with PMCPA's most harsh censures.
Britannia, Vifor, AbbVie, Allergan, Advanced Accelerator Applications (now owned by Novartis) and Otsuka’s Europe and U.K. business were all found in breach of a series of the PMCPA code.
All pharmas in the U.K. voluntarily sign up to the PMCPA and agree to abide by its rules. PMCPA works as a watchdog that polices the marketing and advertising of pharmas working in the U.K.
Britannia and Vifor were the two slapped the hardest, as the PMCPA essentially publicly shamed them.
The PMCPA had already reprimanded Vifor, a kidney specialist that CLS recently bought, in February. The issue was Vifor's “failure to provide accurate and truthful information to the Code of Practice Panel [which rules on the PMCPA’s code] and its disingenuous approach to responding to the complaints,” according to the watchdog.
PMCPA's rebuke was for the “misleading and inaccurate claims” Vifor made about how much better its iron injection treatment Ferinject was compared to a competitor.
As part of this mismarketing, the PMCPA had to audit the company, which took place this summer but found nothing had changed.
“At the consideration of the report of the second re-audit and Vifor’s response, the Appeal Board decided that Vifor should be publicly reprimanded for its lack of progress,” the PMCPA said in its ruling. And so, Vifor will need to be audited again in the fall.
Next up for the most serious censure is Britannia, which was also audited after its initial reprimand last year. The specialty pharma focusing on neuro meds got in hot water for the way it paid and used healthcare professionals on its behalf for speaking events.
Britannia was found in breach of a total of six clauses of the PMCPA’s code, including clause 2—bringing discredit upon and reducing confidence in the pharmaceutical industry—the most serious of breaches.
Like Vifor, the PMCPA did not believe that Britannia dealt with the audit in a satisfactory way and therefore hit it for further censure. “Britannia should be publicly reprimanded for its failure to have the necessary control of its activities with regard to compliance with the Code and its failure to provide a third-party report when first requested,” the regulator said.
Meanwhile, the PMCPA called out AbbVie and Allergan for social media marketing snafus. AbbVie was rapped for promoting eye pressure implant Durysta on LinkedIn before it had marketing authorization to do so. While Allergan, now owned by AbbVie, was chastised for social media posts that referred to unlicensed medicines and promoted Botox to the public.
Neither received the highest censure that Vifor and Britannia did, but they got close. AbbVie and Allergan were also hit for breaching clause 2 but were not publicly reprimanded.
It was the same story for Novartis’ Advanced Accelerator Applications and the U.K. and European business of Japanese pharma Otsuka. AAA was found to be marketing its med, the experimental prostate cancer therapy 177Lu-PSMA-617, before regulatory approval, while Otsuka was lambasted for “omitting the frequency of dosing” from the prescribing information for its atypical antipsychotic Abilify/Abilify Maintena.